Recruiting

Montelukast

Sponsor:

Corrie Fletcher

Code:

NCT01770899

Conditions

Status Asthmaticus

Eligibility Criteria

Sex: All

Age: 2 - 14

Healthy Volunteers: Not accepted

Interventions

Montelukast

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the effectiveness of oral montelukast (Singulair) given with other standard asthma medications and treatments in the treatment of children with status asthmaticus. Status asthmaticus is an acute asthma attack that does not respond to standard intermittent treatments but requires a continuous medication to aid in breathing. While new medications have been used to better manage chronic asthma, acute asthma exacerbations continue to be a significant cause of hospitalization and even death in children. Oral montelukast is a very safe medication that is used to manage chronic asthma in children, but it has not been studied for use in status asthmaticus. If oral montelukast, given with other standard therapies, can reduce the treatment length associated with severe, acute asthma exacerbations in children, it could potentially improve both the morbidity and burden of pediatric asthma.

Conditions

Status Asthmaticus

Study ID

NCT01770899

Start date

Jan, 2013

Status verified date

Feb, 2013

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 14

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Between ages 2-148 years
  • Requiring PICU admission for status asthmaticus
  • Able to take oral medication
  • Pediatric asthma score > 8 on admission

Exclusion criteria:

  • Intubated patients or other patients unable to take medications by mouth secondary to anatomic or pre-existing craniofacial issues
  • Patients already on montelukast as their controller medication
  • Patients with a known allergy to montelukast
  • Any patient with phenylketonuria (PKU)
  • Any patient currently on treatment with rifampin, fluconazole, or Phenobarbital medications

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Montelukast

Montelukast 5mg capsules for 2-5 year old every 24h and 8mg capsules for 6-14 year olds every 24h.

placebo comparator: Placebo

One placebo capsule given every 24h

Interventions

Montelukast

Placebo

Gelatin capsule given every 24 hours

Primary outcome measure

  • Improvement of pediatric asthma score [ Time Frame: Hourly during the length of the patient's pediatric ICU hospitalization for status asthmaticus ]

Central Contacts and Locations

Central contacts

Corrie E Fletcher, DO

708-684-1308corrie.fletcher@advocatehealth.com

Luis Torero, MD

708-684-5685luis.torero@advocatehealth.com

Locations

Advocate Children's Hospital Oak Lawn

Recruiting

Oak Lawn, Illinois, United States, 60453

Principal Investigator:

Corrie Fletcher, DO

More Information

Sponsor

Corrie Fletcher

Last update posted

Feb 25, 2013

Last verified

Feb, 2013

Keywords

  • Montelukast
  • Singulair
  • status asthmaticus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corrie Fletcher on 2013-02-25.